Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT01128465
First received: February 22, 2010
Last updated: March 16, 2011
Last verified: March 2011
  Purpose

Certain kind of neurosurgical procedures require intraoperative alertness of the patient, for example to perform speech tests during brain tumor resection. With respect to anaesthesia, it is therefore required that the patient is asleep during the beginning and the end of the procedure, however fully awake in between. To do so, the anaesthetic propofol is used and an accurate knowledge of its pharmacokinetic and -dynamic (pk/pd) parameters is required to optimally control anaesthesia. However, diverse pk/pd-parameter sets have been described in the literature.

The aim of the study is to investigate whether the pk/pd model proposed by Marsh et al. or by Schnider et al. more accurately describe the pk/pd of propofol during awake craniotomy.


Condition
Brain Tumor

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Investigation on the Pharmacokinetic and -Dynamic of Propofol During Awake Craniotomy

Resource links provided by NLM:


Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • prediction error for propofol plasma concentrations [ Time Frame: day of surgery (day 1) ] [ Designated as safety issue: No ]
    On the day of surgery, plasma samples will be drawn during induction, maintenance and recovery from anesthesia. Subsequently the actually measured propofol plasma concentration will be compared with the predicted propofol plasma concentration (according to Marsh et al. and Schnider et al.), and the prediction error will be calculated.


Biospecimen Retention:   Samples Without DNA

plasma


Estimated Enrollment: 10
Study Start Date: February 2010
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients of a University Hospital requiring an awake craniotomy for resection of a brain tumor or lesion

Criteria

Inclusion Criteria:

  • patients scheduled for awake craniotomy

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01128465

Locations
Germany
Dept. of Anaesthesiology and Intensive Care Medicine, Univ. of Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
Investigators
Principal Investigator: Martin Soehle, MD, DESA, D habil Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn, Germany
  More Information

Publications:
Responsible Party: Martin Soehle, MD, DESA, Dept. of Anaesthesiology and Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT01128465     History of Changes
Other Study ID Numbers: AC
Study First Received: February 22, 2010
Last Updated: March 16, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:
propofol
awake craniotomy
patients requiring an awake craniotomy for brain tumor/lesion resection

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 21, 2014